TRAnexamic Acid for Preventing postpartum hemorrhage following a Cesarean Delivery

Phase 1

• Conditions: Postpartum hemorrhage, prevention, blood loss, transfusion; MedDRA version: 20.0Level: PTClassification code 10036417Term: Postpartum haemorrhageSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; MedDRA version: 20.0Level: SOCClassification code 10036585Term: Pregnancy, puerperium and perinatal conditionsSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-001144-36-FR
• Lead Sponsor: CHU de Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-12
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 4524

Inclusion Criteria

adult women admitted for a cesarean delivery before or during labor, at a term = 34 weeks, hemoglobin level at the last blood sample >9g/dl, blood Formula numbering within 3 days before caesarean delivery, informed signed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4524
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

previous thrombotic event or preexisting pro-thrombotic disease, epilepsy, any known cardiovascular, renal, liver disorder, severe hemorrhagic disease, autoimmune disease, sickle cell disease, placenta praevia, placenta accreta/increta/percreta, abruption placentae, eclampsia, HELLP syndrome, in utero fetal death, administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery, general anesthesia, instrumental extraction failure, multiple pregnancy with genital delivery of the first twin and caesarean delivery for the second or at third trimester

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified